# K013274: Mono-Dox, Synthetic Absorbable Polydioxanone Surgical Suture,Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Cp Medical
- Decided: Nov 16, 2001 after 46 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) PDS II, Synthetic Absorbable Polydioxanone Surgical Sutures: named in the summary without a submission number

## Most influential descendants
- K030212: Monodek Synthetic Absorbable Surgical Suture (2003), 12 descendants of its own
- K181774: Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture (2018), 10 descendants of its own
- K031443: Lsi Solutions Suture Quick Load Products (2003), 7 descendants of its own
- K100593: Suture Placement Device and Accessories, Flexible Suture Placement Device and Accessories, Lsi R Series Suture Placeme (2010), 5 descendants of its own
- K230311: HyperSuture (2023), 4 descendants of its own

## Recalls of this device
- Jan 2, 2009 · Not classified · Z-0259-2012: The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.
- Sep 17, 2008 · Not classified · Z-2582-2010: Seal integrity of inner foil pouch of the Mono-Dox Synthetic Absorbable Suture may be compromised.
- Apr 3, 2007 · Not classified · Z-0809-2007: Potential for sterility of product to be compromised. Suture package seals incomplete or missing.

## Indications for use
Mono-Dox, Monofilament Synthetic Absorbable Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Mono-Dox suture is not indicated for use in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.

Source page: https://510kreport.com/device/K013274
Methodology: https://510kreport.com/methodology